It has been recognised in the past that there is a benefit in providing accurate information to a user of dispensing apparatus, such as pressurised metered dose inhalers (pMDIs), concerning the quantity of doses delivered from, or remaining in, the dispensing apparatus. Without such information, there is a risk that a user may be unaware that the dispensing container of the dispensing apparatus is empty or close to empty. This is a particular problem where the dispensing apparatus is for use in delivering medicinal compounds for the treatment of chronic or acute symptoms, for example, as in the case of a pMDI used for treating conditions such as asthma.
A pMDI typically comprises a pressurised dispensing container that is received in an actuator housing. The actuator housing will comprise an outlet through which substance can be dispensed. The outlet will typically be adapted for oral, nasal or sub-lingual delivery of the substance. The pressurised dispensing container typically comprises a canister which defines a storage volume for the substance to be dispensed, wherein an open end of the canister is closed by means of a metering valve. The metering valve is designed to accurately and consistently dispense a predetermined volume of substance on each actuation of the pMDI. The substance to be dispensed may be one of a wide range of substances. Typically, the substance will include one or more active components (such as medicaments) and a propellant that is volatile at standard pressures and temperatures.
To prepare a pMDI (or other dispensing apparatus) for use, it may be necessary to prepare or “prime” the metering valve of the pMDI by carrying out one or more actuations of the pMDI (which are not administered to the user) before putting the pMDI to normal use. Such priming actuations are designed to ensure that the metering valve of the pMDI is properly charged with the substance to be dispensed—since a metering chamber of the metering valve may initially be wholly or partly empty immediately after assembly of the pMDI. Thus the priming actuations are carried out to ensure that a full dose is delivered on the first ‘normal’ actuation by the user where administration of the substance is desired.
It is preferred that the priming actuations are carried out by the user when they first receive the pMDI, for example from a doctor or pharmacy, so that the metering valve is not potentially left for a long time between priming and its first normal use. Thus, there is a need for the instructions for the priming of the pMDI to be clear to the user. It is also preferable for any dose counter, that is present in the pMDI, not to record the priming actuations as dispensed doses. Rather, it is preferred that the dose counter should indicate that the pMDI is ‘full’ or shows the first it its series of numerical or other indicia after the priming actuations are completed.
EP2514468 describes a dose counter for a pMDI which comprises a tape reel bearing dose indicia that is moved from a first shaft to a second shaft past a viewing window during use of the pMDI. Priming dots are provided at the start of the tape reel which are initially displayed to a user to prompt them to carry out three priming actuations wherein the tape reel then displays the start of the sequence of numerical count indicia. Each portion of the tape reel is only viewed once by the user as it transits past the viewing window.
However, the use of priming dots at the start of a tape reel as described in EP2514468 is not suitable for use with dose counters of the type having one or more rotatable indicator members, especially where one or more of the rotatable indicator members may need to complete more than one revolution during the life of the dispensing apparatus.
According to the present disclosure there is provided a dose counter for displaying a count indication of the number or quantity of doses dispensed from or remaining in a container associated, in use, with the dose counter,
the dose counter comprising:                an indicator member comprising dose indicia; and        a priming indicator for prompting a user to carry out one or more priming actuations of the container;        
wherein the priming indicator is initially arranged to at least partially overlie the indicator member to thereby at least partially obscure viewing of the dose indicia of the indicator member until the one or more priming actuations of the container have been completed;
wherein the priming indicator is movable after the one or more priming actuations have been completed into a disposition where it no longer obscures viewing of the dose indicia of the indicator member.
Advantageously, by using a priming indicator that at least partially obscures viewing of the dose indicia of the indicator member until the one or more priming actuations of the container have been completed, a simple and clear means of instructing the user to prime the dispensing apparatus is achieved. The use of the priming indicator does not negatively impact the readability of the dose indicia after the priming actuations have been completed. In addition, by making use of a priming indictor that at least partially overlies the indicator member the priming indicator finds use with a wide range of dose counter arrangements, especially those including one or more rotatable indicator members.
The priming indicator may be movable into the disposition where it no longer obscures viewing of the dose indicia of the indicator member by movement of the indicator member itself. In such a case, a simpler construction of dose counter may be achieved as no separate means need be provided to provide a motive force for moving the priming indicator.
The priming indicator may be initially coupled to the indicator member to thereby be moved with the indicator member during the one or more priming actuations. Thus, the priming indicator and the indicator member may be arranged to move in-sync with one another during the one or more priming actuations. Advantageously, the mechanism of the dose counter provided to achieve movement of the indicator member (which may be any one of a number of possible mechanisms) may also be used to move the priming indicator—avoiding the need for any separate source of motive force.
In such a case, the priming indicator is preferably able to be decoupled from the indicator member after the one or more priming actuations have been completed. Thus, during the remainder of the life of the dispensing apparatus movement of the indicator member need not move the priming indicator.
There are a number of possible means for decoupling the priming indicator. One possibility is that the priming indicator is able to be decoupled from the indicator member by the action of gravity. This allows for a simple arrangement where, for example, the priming indicator drops out of its coupled configuration.
The indicator member may comprise a rotatable member. In one example the indicator member comprises an annular ring wherein the dose indicia may be arranged on an outer peripheral face of the annular ring.
The indicator member and the priming indicator may comprise co-operating formations for coupling the priming indicator to the indicator member.
There are a number of possible configurations of co-operating formations for coupling the priming indicator to the indicator member. One possibility is where the co-operating formations comprise one or more legs provided on the priming indicator and one or more apertures in the indicator member. The one or more apertures may, for example, comprise one or more notches or indentations in an edge of the indicator member. In such a case, coupling may be achieved when the one or more legs of the priming indicator are engaged in the one or more apertures and decoupling may be achieved when the one or more legs are allowed to disengage from the one or more apertures. Preferably, the dispensing apparatus would be provided to the user with the priming indicator initially coupled to the indicator member—in this example, therefore with the one or more legs initially engaged with the one or more apertures. The use of notches or indentations in the edge of the indicator member may have the advantage of allowing easier decoupling of the priming indicator since decoupling can be achieved with a greater degree of choice of the direction of movement of the priming indicator relative to the indicator member. For example, the one or more legs may be moved either perpendicularly or parallel to the plane of the indentation or notch.
The priming indicator may be movable after the one or more priming actuations have been completed into a disposition where it no longer overlies the indicator member. In this position the priming indicator may, for example, be parked for the remainder of the life of the dispensing apparatus.
In some examples, the indicator member may form a first indicator member of the dose counter and the dose counter may further comprise a second indicator member; the first and second indicator members acting in combination to display the count indication. The use of two (or more) indicator members in combination may be useful in a number of circumstances. In one example, the two indicator members can be used to display a greater number of dose indicia than would be possible on a single indicator member. In another example, the two indicator members could display different, for example associated, indicia—for example, with the first indicator member displaying a numerical count and the second indicator member displaying a colour indication.
In such a case, the first indicator member may, for example, be arranged to move on each actuation of the associated container and the second indicator member may be arranged to move after a predetermined number of incremental movements of the first indicator member. Such an arrangement may be used wherein the dose indicia of the first indicator member displays a ‘units’ numeral (or other suitable marking/colour/indicia) of the count indication and wherein the second indicator member comprises dose indicia which display a ‘tens’ numeral (or other suitable marking/colour/indicia) and, optionally additionally a ‘hundreds’ numeral (or other suitable marking/colour/indicia) of the count indication.
It may be advantageous for the first indicator member to comprise a plurality of sequentially arranged arrays of ‘units’ numerals, each array ranging from ‘9’ to ‘0’. Thus one complete revolution of the first indicator member may be configured to increment the second indicator member a plurality of steps.
Where the dose counter comprises at least two indicator members, the priming indicator may be initially arranged to at least partially overlie the first indicator member and to at least partially overlie the second indicator member to thereby at least partially obscure viewing of the dose indicia of both the first and second indicator members. This helps to prevent any of the dose indicia being mistakenly read until the one or more priming actuations have been completed.
Where the dosage counter comprises first and second indicator members, the priming indicator may be initially coupled to the first indicator member to thereby be carried with the first indicator member and to be moved relative to the second indicator member during the one or more priming actuations. The priming indicator may be arranged to be decoupled from the first indicator member after the one or more priming actuations have been completed. Optionally, the priming indicator may be arranged to become coupled with the second indicator member on decoupling from the first indicator member. Optionally, after coupling of the priming indicator to the second indicator member, the priming indicator may be carried with the second indictor member during subsequent actuations of the associated container. In such a case, it is preferred that the second indicator member is configured to complete less than a complete revolution (in the case of the indicator members being rotatable indicator members) during the lifetime of the dispensing apparatus so as to prevent the priming indicator returning into a position where it again obscures viewing of the dose indicia.
The first indicator member and the second indicator member may both comprise a rotatable member. The first indicator member and the second indicator member may each comprise an annular ring having dose indicia arranged on an outer peripheral face of the annular ring. The first indicator member, the second indicator member and the priming indicator may comprise co-operating formations for coupling the priming indicator initially to the first indicator member and subsequently to the second indicator member. As described above, the co-operating formations may, by way of example, comprise one or more legs provided on the priming indicator and one or more apertures in the first and second indicator members. The one or more apertures may comprise one or more notches or indentations in an edge of the first and/or second indicator members.
As in the above example, the priming indicator may be movable after the one or more priming actuations have been completed into a disposition where it no longer overlies the first indicator member.
According to the present disclosure the priming indicator may be a separate component from the indicator member. For example, the priming indicator may be a relatively small shutter-like component. The priming indicator may be shaped to conform generally to the shape of the first and/or second indicator member. For example, where the indicator member(s) are annular rings the priming indicator may comprise a body that is generally curved to match the curvature of the annular rings.
The priming indicator may comprise priming indicia suitable for viewing in place of the dose indicia of the indicator member until the one or more priming actuations of the container have been completed.
The present disclosure also provides a dispensing apparatus comprising a dose counter as described above.
The dispensing apparatus may further comprise a container containing a quantity of substance to be dispensed.
The dispensing apparatus may comprise a viewing window for viewing the count indication of the dose counter, wherein the priming indicator is initially arranged at least partially inbetween the indicator member and the viewing window to thereby at least partially obscure viewing of the dose indicia of the indicator member until the one or more priming actuations of the container have been completed;
wherein the priming indicator is movable after the one or more priming actuations have been completed into a disposition where it is no longer inbetween the viewing window and the indicator member.
In one example, the dispensing apparatus is a pressurised metered dose inhaler (pMDI). Another example of a use of a suitable dispensing apparatus is a pump, for example a nasal, oral or sub-lingual pump device.
The dose indicia of the indicator member(s) may be of any suitable type for conveying the necessary information to the user. Examples include numbers, letter, colours and pictograms. Such indicia may be used in combination if desired. For example, number indicia may be used as the main indicia (for example counting down from ‘200’ to ‘000’ doses remaining) combined with a change of colour indicia as the empty point approaches (for example the ‘tens’ or ‘hundreds’ indicator member may be provided with a red zone at or near the empty point).
The priming indicia of the priming indicator may be of any suitable type for conveying the necessary information to the user. Examples include dots, numbers, colours or pictograms. Preferably a different style of indicia is chosen for the priming indicia compared to the dose indicia.
The dispensing apparatus may be a pharmaceutical dispensing apparatus, such as, for example, a pulmonary, nasal, or sub-lingual delivery device. A preferred use of the dispensing apparatus is as a pressurised metered dose inhaler device for delivering a pharmaceutical in an aerosol form. Another use of the dispensing apparatus is as a pump device. The term pharmaceutical, as used herein, is intended to encompass any pharmaceutical, compound, composition, medicament, agent or product which can be delivered or administered to a human being or animal, for example pharmaceuticals, drugs, biological and medicinal products. Examples include antiallergics, analgesics, bronchodilators, antihistamines, therapeutic proteins and peptides, antitussives, anginal preparations, antibiotics, anti-inflammatory preparations, hormones, or sulfonamides, such as, for example, a vasoconstrictive amine, an enzyme, an alkaloid, or a steroid, including combinations of two or more thereof. In particular, examples include isoproterenol [alpha-(isopropylaminomethyl) protocatechuyl alcohol], phenylephrine, phenylpropanolamine, glucagon, adrenochrome, trypsin, epinephrine, ephedrine, narcotine, codeine, atropine, heparin, morphine, dihydromorphinone, ergotamine, scopolamine, methapyrilene, cyanocobalamin, terbutaline, rimiterol, salbutamol, ipratropium bromide and salbutamol, flunisolide, colchicine, pirbuterol, beclomethasone, orciprenaline, fentanyl, and diamorphine, streptomycin, penicillin, procaine penicillin, tetracycline, chlorotetracycline and hydroxytetracycline, adrenocorticotropic hormone and adrenocortical hormones, such as cortisone, hydrocortisone, hydrocortisone acetate and prednisolone, insulin, cromolyn sodium, and mometasone, including combinations of two or more thereof.
The pharmaceutical may be used as either the free base or as one or more salts conventional in the art, such as, for example, acetate, benzenesulphonate, benzoate, bircarbonate, bitartrate, bromide, calcium edetate, camsylate, carbonate, chloride, citrate, dihydrochloride, edetate, edisylate, estolate, esylate, fumarate, fluceptate, gluconate, glutamate, glycollylarsanilate, hexylresorcinate, hydrobromide, hydrochloride, hydroxynaphthoate, iodide, isethionate, lactate, lactobionate, malate, maleate, mandelate, mesylate, methylbromide, methylnitrate, methylsulphate, mucate, napsylate, nitrate, pamoate, (embonate), pantothenate, phosphate, diphosphate, polygalacturonate, salicylate, stearate, subacetate, succinate, sulphate, tannate, tartrate, and triethiodide, including combinations of two or more thereof. Cationic salts may also be used, for example the alkali metals, e.g. Na and K, and ammonium salts and salts of amines known in the art to be pharmaceutically acceptable, for example glycine, ethylene diamine, choline, diethanolamine, triethanolamine, octadecylamine, diethylamine, triethylamine, 1-amino-2-propanol-amino-2-(hydroxymethyl)propane-1,3-diol, and 1-(3,4-dihydroxyphenyl)-2 isopropylaminoethanol.
The pharmaceutical will typically be one which is suitable for inhalation and may be provided in any suitable form for this purpose, for example as a solution or powder suspension in a solvent or carrier liquid, for example ethanol, or isopropyl alcohol. Typical propellants are HFA134a, HFA227 and di-methyl ether.
The pharmaceutical may, for example, be one which is suitable for the treatment of asthma. Examples include salbutamol, beclomethasone, salmeterol, fluticasone, formoterol, terbutaline, sodium chromoglycate, budesonide and flunisolide, and physiologically acceptable salts (for example salbutamol sulphate, salmeterol xinafoate, fluticasone propionate, beclomethasone dipropionate, and terbutaline sulphate), solvates and esters, including combinations of two or more thereof. Individual isomers such as, for example, R-salbutamol, may also be used. As will be appreciated, the pharmaceutical may comprise of one or more active ingredients, an example of which is flutiform, and may optionally be provided together with a suitable carrier, for example a liquid carrier. One or more surfactants may be included if desired.
Rigid components of the dispensing apparatus may be formed from, for example, from polyester, nylon, acetal or similar.